WHO ICTRP trial
A study of efficacy and safety of LAG525 in combination with spartalizumab, or…
EUCTR2017-004865-28-GB · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2017-004865-28-GB |
|---|---|
| Public title | A study of efficacy and safety of LAG525 in combination with spartalizumab, or with spartalizumab and carboplatin, or with carboplatin, in patients with advanced triple-negative breast cancer. |
| Scientific title | A phase II open-label, randomized, three-arm, multicenter study of LAG525 given in combination with spartalizumab (PDR001), or with spartalizumab and carboplatin, or with carboplatin, as first or second line therapy in patients with advanced triple-negative breast cancer |
| Primary sponsor | Novartis Pharma AG |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no |
| Countries | United States;Taiwan;Spain;Thailand;Lebanon;Israel;Italy;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Singapore;Australia;Germany;Japan;Korea, Republic of |
| Conditions | triple negative breast cancer MedDRA version: 20.0 Level: LLT Classification code 10072740 Term: Locally advanced breast cancer System Organ Class: 100000004864 ;Therapeutic area: Diseases [C] - Cancer [C04] |
| Interventions | Product Code: LAG525 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: not established Current Sponsor code: LAG525 Other descriptive name: LAG525 Concentration unit: mg/ml milligram(s)/millilitre Concentration… |
| Registration date | Jan 5, 2018 |
| Target size | 84 |
| Secondary IDs | CLAG525B2101 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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About WHO ICTRP trial registrations
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: